fda

FDA proposes pulling Sudafed and Benadryl from pharmacy shelves

https://www.fda.gov/news-events/press-announcements/fda-grants-first-marketing-authorization-dna-test-assess-predisposition-dozens-cancer-types

The US Food and Drug Administration (FDA) has approved efgartigimod (Vyvgart, argenx), a first-in-class, targeted therapy for adults with generalized myasthenia gravis (gMG) who test positive for the antiacetylcholine receptor (AChR) antibody... Full text at...

https://www.nytimes.com/2021/08/12/health/GHB-hypersomnia-sleep-FDA.html?referringSource=articleShare For idiopathic hypersomnia. Article mentions fibromyalgia. Not sure why there were 27,000 serious adverse events if there are only 15,000 prescriptions.

https://www.fiercebiotech.com/biotech/fda-rejects-gilead-s-would-be-blockbuster-filgotinib-over-toxicity-concerns Testicular toxicity! Wow—This is the drug KDM was promoting, and planning to do trials with. See here...

Dietary Supplements Pose Real Dangers to Patients Full text here Abstract The Dietary Supplement Health and Education Act led to a flood of poor-quality dietary supplements. The Food and Drug Administration’s (FDA’s) jurisdiction is limited to removing products proven unsafe, rather than...

https://www.pharmacytimes.com/news/fda-approves-pitolisant-for-daytime-sleepiness-in-patients-with-narcolepsy Wonder if this could help with fatigue in mecfs?

The Guardian: 'Church' to offer 'miracle cure' despite FDA warnings against drinking bleach https://www.theguardian.com/us-news/2019/apr/19/church-group-to-hold-washington-event-despite-fda-warnings-against-miracle-cure

"Based on new draft guidance it seems that the FDA and NIH are teaming up in a big new way to punish those who are non-compliant with the Clinicaltrials.gov-related regulations and laws, including potentially with large fines. What do sponsors of specific listings do that’s so bad? There are a...

Scientific American article on the search for an Alzheimer's biomarker, and how both the FDA and Bill Gates have made finding an inexpensive blood test for Alzheimer's a priority. We Need New Biomarkers for Alzheimer's Disease They're essential to coming up with better treatments, and a new...

Recall Alert: FDA Warning About Two Thyroid Medications August 15, 2018 at 1:00 pm PITTSBURGH (KDKA) — The Food and Drug Administration has a new warning and recall about two thyroid medications made by a Chinese manufacturer. The FDA has issued a voluntary recall for the medications because...

https://www.nationalmssociety.org/About-the-Society/News/FDA-Expands-Use-of-Gilenya®-(fingolimod)-for-Child (bolding in original)

https://www.forbes.com/sites/robinseatonjefferson/2018/04/27/report-offers-hope-outlines-537-new-drugs-in-development-for-neurological-disorders/

https://www.everydayhealth.com/multiple-sclerosis/treatment/new-guidelines-ms-treatment-start-treatment-early/

Wired: Bad results from drug trials no longer have a place to hide In 2007, US Food and Drugs Administration (FDA) Amendments Act was passed. The law laid out many different ways to try and improve the way new drugs are developed, including a publicly-available database of all clinical trials...

https://www.washingtonpost.com/news/to-your-health/wp/2017/12/18/fda-to-target-homeopathic-drugs-that-pose-safety-risks/

https://www.fda.gov/Drugs/NewsEvents/ucm574725.htm?platform=hootsuite On December 18th, FDA is conducting a public workshop to convene a discussion on methodological approaches that a person seeking to collect patient experience data for submission to FDA to inform regulatory decision-making...

http://www.raredr.com/news/fda-approves-mepsevii "'This approval underscores the agency’s commitment to making treatments available to patients with rare diseases,' said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research...

I found this report from 2013 which I think is pretty good and accurate (I'm only skimmed thro it though). It is more than the title would suggest. It's a shame that it would seem nothing resulted from it...